Astellas Pharma Inc. recently announced results from a post hoc analysis of the phase 3 clinical trials of IZERVAY (avacincaptad pegol) evaluating its impact the risk of progressing to loss of driving eligibility in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
This latest research was presented earlier this month during the 2026 Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver, Colorado.
Let’s begin with a refresher on IZERVAY.
First approved in 2023, the prescription-based C5 inhibitor made history in becoming the first—and still only—GA treatment with a statistically significant reduction in the rate of disease progression at the 12-month primary endpoint in clinical trials.
IZERVAY’s FDA approval was based on two phase 3 pivotal clinical trials:
- GATHER1 (NCT02686658): Patients received IZERVAY EM or sham for 18 months
- GATHER2 (NCT04435366): Patients were given IZERVAY EM or sham for 12 months, after which they were re-randomized to IZERVAY EM or EOM for up to 24 months
Its dosing schedule: 2 mg (0.1 mL of 20 mg/mL solution) is to be administered by intravitreal (IVT) injection to each affected eye once a month (EM) or every other month (EOM), with no limitation on the duration of its dosing.
Let’s move on to the post hoc analysis.
This study included patients who were eligible to drive at baseline, defined by best-corrected visual acuity (BCVA) of ≥70 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters.
The risk of progressing to loss of driving eligibility was evaluated, which was defined as ≤60 ETDRS letters seen at two consecutive post-baseline visits, over a 24-month period in the study eye.
Findings?
At the start of the study, enrolled patients (n=403) who either received IZERVAY or sham had similar vision (76.2 letters vs. 76.0 letters).
However: At 24 months the risk of progressing to loss of driving eligibility was 12.6% for IZERVAY EM or EOM compared to 20.1% for sham, representing a 41% relative risk reduction for IZERVAY (nominal p=0.0594).
- Plus: Similar results were seen for patients who switched from IZERVAY EM to EOM dosing.
What this means: Treatment with IZERVAY reduced the risk of progressing to loss of driving eligibility by 41% compared with sham over 24 months in patients with GA.
Anything else?
When analyzing IZERVAY EM dosing only vs. sham, the risk of progressing to loss of driving eligibility was 15.1% for IZERVAY compared to 20.1% for sham, a 35% reduction in relative risk (nominal P=0.1584).
Important to note: The nominal P values did not meet conventional thresholds for statistical significance—and given the exploratory nature of post hoc analyses, these results should be interpreted with caution and cannot be considered conclusive.
Any other new IZERVAY data to keep in mind?
Findings from an encore presentation of the GATHER2 open-label extension (OLE) study—which evaluated patients with GA secondary to AMD—demonstrated IZERVAY was well-tolerated with “no new safety signals, no cases of retinal vasculitis, and on increased intraocular inflammation.”
Further: “Exploratory, longer-term data from the GATHER2 OLE also showed how IZERVAY sustained slowing of GA lesion growth over time, with earlier intervention resulting in greater protection of healthy retinal tissue area.”
Can we get some numbers on this?
To be exact: The mean change in GA lesion growth area was reduced by:
- 40.5% from month 24 (mm2/year) compared to predicted sham in patients who switched from IZERVAY EM/EOM to IZERVAY EM at 3.5 years (p<0.001)
- 37% from month 24 (mm2/year) compared to projected sham in the IZERVAY EM group who previously received sham (p<0.001)
Anything else going on with Astellas?
Indeed. Astellas was busy at ARVO, where they also announced preliminary safety and tolerability findings from phase 1b data on ASP7317 for advanced GA secondary to AMD.
Click here to read more about the early data on ASP7317.